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Who Says Technology Transfer Doesn't Pay?

Son of Neurontin Meets the Fibromyalgia Epidemic

by MARTHA ROSENBERG

Who says technology transfer doesn’t pay?

Pregablin, discovered by Northwestern University chemist Richard Silverman in 1989 to become Pfizer’s Lyrica, earned the university a cool $700 million when it sold royalties in Dec. 2007.

The nerve pain-cum-seizure pill is funding the $100 million Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics–currently a hole in the ground on the way to the student union–which will employ 245 this fall. Views of Lake Michigan and the duck pond included.

And, thanks to FDA approval in 2007 of Lyrica as the first US drug for the pain condition fibromyalgia, it may earn as much as its molecular relative–Pfizer’s Neurontin (gabapentin)–which made $3 billion a year before its patent ran out in 2004.

No wonder they call Lyrica son of Neurontin.

Of course there have been setbacks on the road to marketing Lyrica.

In 2001, Pfizer had to freeze pain trials and restrict pregablin in patients when test mice developed cancerous tumors. Profit warning! But when rats tests were okay, Toni Hoover, a vice president with Pfizer’s now defunct Ann Arbor, MI labs sounded the all clear. “The FDA has found that the benefit of taking the drug outweighs any risk,” she told the Detroit News.

Pfizer brass failed to embrace Silverman the way it embraced the $564 million he made for them in Lyrica’s first three months. (“They had a launch party for the drug, and I asked to come. Nope. No party for me. They take your stuff and tell you to go away,” he told the Chicago Tribune.)

And Lyrica’s not approved for the “social phobia” detailed in Pfizer original marketing plans. Yet.

But as long as pharma can get a drug approved in advance of its uses and people will take an antipsychotic for the blues or a seizure med for migraines, Lyrica has a future.

Initial articles about Lyrica which, like Neurontin, is an anti-seizure drug that modulates calcium channels to dampen the excitability of nerve endings, were positive.

“Well tolerated,” said Arthritis and Rheumatism in 2005.

“Proven efficacy” and “No new adverse events,” said Drugs of Today in 2005 and 2007.

“Durability of effect for relieving FM pain,” said the journal Pain in 2008.

Unfortunately the articles were all written by Pfizer paid doctors.

Actual users of Lyrica report memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and a lot of I’d-rather-have-my-fibro-symptoms-back-if-this-is-the-cure on askapatient.com. P.S. There are two deaths.

Of course its no secret that Pfizer’s blockbusters Viagra, Zoloft and Lipitor are history and its pipeline is bare. In January, it announced it was losing 800 of its researchers and buying Wyeth (no danger of getting new researchers there.)

Nor can its gravy train of antibiotics in food animals–pun intended–last much longer with residues found in meat, water and even crops and world recognition of antibiotic resistance.

Just as people were forgetting that Pfizer paid $430 million in 2004 for criminally promoting Neurontin for bipolar disorder, attention-deficit disorder, restless legs syndrome and other unapproved disorders, an article in the January 9 New England Journal of Medicine titled “The Neurontin Legacy–Marketing through Misinformation and Manipulation,” shows it’s déjà vu all over again at Pfizer.

Nor is Lyrica the only game in town anymore for fibromyalgia since the FDA approved Lilly’s antidepressant Cymbalta in 2008 and Forest Laboratories’ antidepressant Savella in January. Now Americans can choose between an antidepressant with a black box warning for suicide and a seizure medication for a disease they didn’t know they had–or was an epidemic–ten years ago.

Lyrica itself was slated for an FDA black box suicide warning in 2008. A 92-page appeal from Pfizer last summer called the suicide stats “an exaggeration of risk that is introduced by ascertainment bias” and cautioned against “overwarning…patients and prescribers” so that they “underestimate the risks of declining treatment.” Especially risks for Pfizer.

As Northwestern students negotiate the snow and construction at the future home of the Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics, any pain they feel is from all-nighters, all-you-can-drink nights and the cold–not fibromyalgia. Few will remember Lyrica when classes start in the new science hall. Nor can a building be withdrawn.

MARTHA ROSENBERG is a columnist/cartoonist who writes about public health. She can be reached  at martharosenberg@sbcglobal.net